EMA Approves Three Oncology Drugs, Rejects One
This article was originally published in The Pink Sheet Daily
Cancer drugs had a triumphant day at the European Medicines Agency on July 20, led by Pfizer’s Xalkori, with only one (Celgene’s Istodax) failing to make the grade.
You may also be interested in...
The oncology biotech is plowing ahead with its late-stage study of sapacitabine, despite unfavorable findings during an interim analysis.
The European pharmaceutical industry has refuted claims that manufacturers are exploiting a loophole in EU legislation to avoid running non-lucrative trials for pediatric oncology drugs.
The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia because the pivotal study failed to demonstrate a statistically significant survival benefit in the pre-specified primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.